About CLSI

Find Answers to Volunteering & Standards Questions

First, you may write a letter or an e-mail stating your field of interest. You should also include an updated CV. Staff will notify you when a committee is forming for a project in your area of interest. You may also visit the Volunteer section of our website to browse CLSI’s committees and projects, and volunteer for a specific committee using a nomination form. Whether you send an open letter or a nomination form, a member of the CLSI staff will respond to your submission with a letter to you, indicating receipt of your request.

Your organization does not need to be a member of CLSI for you to become a volunteer. CLSI has 2,000 volunteers, who work together to develop CLSI documents through CLSI’s consensus process. Learn more about CLSI membership opportunities here.

CLSI offers voluntary consensus standards and guidelines, reports, and a number of companion products.

Standards are documents developed through the consensus process that clearly identify specific, essential requirements for materials, methods, or practices for use in an unmodified form. Standards may, in addition, contain discretionary elements, which are clearly identified.

Guidelines are documents developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. Guidelines may be used as written or modified by the user to fit specific needs.

Reports are documents that have not been subjected to consensus review and are released by the appropriate consensus committee.

Companion products include any item provided or sold that is intended to be used in conjunction with a CLSI standard or guideline. Examples include, but are not limited to, Quick Guides, Wall Charts, software, and templates. Companion products typically contain or refer to technical content taken directly from standards and guidelines.

CLSI voluntary consensus is the agreement among materially affected, competent, and interested parties. Voluntary consensus does not always connote unanimous agreement, but it does mean that the participants have considered and resolved all relevant objections.

Respond to a Call for Volunteers for a new project by sending a statement of interest in participating on the committee. In order to process your request, CLSI needs a current copy of your curriculum vitae and a Disclosure of Interests form (which will be provided to you after your request).

Consensus Committee—oversees development and review of consensus documents within its assigned area of responsibility. The consensus committee ensures the document’s technical accuracy and overall quality throughout the consensus process. All participants should have expertise and experience in the subject area.

Vice-Chairholder—serves as leader and representative of the consensus committee in the chairholder’s absence.

Member—each member is expected to read the Candidate Draft for Advancement and the Consensus Draft carefully during the voting periods, submit a vote, and make any required corrections to ensure the document’s technical accuracy and overall quality prior to publication.

Advisor—identifies topics for consideration for new consensus documents, develops new project proposals, may serve as document development committee or working group chairholder, and provides input on draft documents submitted to the consensus committee for approval.

Document Development Committee—drafts individual consensus documents and revises them to address comments received during the consensus process, considering scientific accuracy, practicality, and comprehensibility in order to create documents with high quality and utility.

Committee participants:

Chairholder—reports to the consensus committee chairholder, develops and implements project budget and schedule, plans and conducts committee meetings, manages development or revision of the document, and monitors participation of committee members and contributors.

Vice-Chairholder—serves as leader and representative in the chairholder’s absence.

Member—develops table of contents, identifies primary references, participates as a contributing author and subject matter expert, completes and votes on the document development committee’s draft document, addresses all comments submitted during the voting stages, and revises drafts as appropriate.

Contributor (formerly Advisor or Observer)—reviews and comments on draft documents. These individuals, who are knowledgeable and experienced in the topic area, provide valuable input on the draft documents.

Committee Secretary—supports the consensus process by providing accurate, technically oriented meeting summaries. The secretary is knowledgeable in the subject area and is able to prepare meeting summaries that include details supporting the rationale for decisions and changes made during the meeting.

CLSI expects member organizations to assume responsibility for the expenses of their representatives serving on CLSI committees.

CLSI may reimburse the travel expenses of committee members representing organizations in the professional and government sectors if the nominating organization is unable to cover these expenses. Such reimbursement must be requested at the time of nomination. (Advisors, Observers, and Contributors are not reimbursed.) This requirement assists CLSI in planning and budgeting for its standards program.

If you are nominating a candidate as a potential committee member, please make every effort to arrange for the responsibility of these expenses. If your organization is unable to assume this responsibility, please check the appropriate box on the online nomination form to request CLSI reimbursement of these expenses (contingent on appointment of your nominee as a committee member).

CLSI documents undergo five stages of development before publication as an approved standard or guideline. The development includes drafting, review, comment, and voting, and follows one of two development tracks. Both tracks have the same five voting stages. During each voting stage, the document development committee addresses any comments, errors, omissions, inconsistencies, or unresolved issues.

For new projects, the individual(s) proposing a new project will indicate, on the project proposal form, the appropriate track designation, Track 1 (15-month timeline) or Track 2 (25-month timeline). For those projects designated as Track 2, proposers are required to provide a rationale for the extended timeline.

Once a project proposal is submitted for endorsement, the consensus committee will determine whether the project will go forward as a Track 1 or Track 2 based on the scope, complexity, comprehensiveness, and depth necessary to cover the topics, and the degree of controversy to be resolved to achieve consensus

Anyone is eligible to review a CLSI draft document. Throughout the document development process, the draft is reviewed by the document development committee and the appropriate consensus committee at specific points in the process. During Voting Stage 2, the document is reviewed by the CLSI delegates and the board of directors. At this time, it is also available for public review. Comments related to CLSI draft documents should be made in writing using the comment table form. These comments, as well as requests for copies of draft documents, should be submitted via e-mail to standard@clsi.org or by fax to 610.688.0700.

Anyone may submit a comment on a CLSI document. All comments are addressed, according to the consensus process, by the CLSI committee that developed the document. Comments either result in a change to a document when published at the next consensus level, or are responded to by the committee in an appendix to the document. Users are strongly encouraged to comment in any form and at any time on any CLSI document.

Comments may be submitted, using our comment form, via email at standard@clsi.org, fax to 610.688.0700, or mail to:

Unresolved objections (ie., “reject” votes) and substantive changes after balloting are reported to the committee, and committee members have the opportunity to respond, reaffirm, or change their votes based upon the stated objection(s).

Unchanged reject votes or unresolved comments are appended to the document as minority opinions, with a notification and request for user input.

Appeal of substantive issues related to the contents of CLSI documents is incorporated in the consensus development process by requiring all relevant objections to be satisfactorily addressed by the respective committee.

The CLSI Administrative Procedures provide for appeal by persons or organizations that have been or will be materially or adversely affected by substantive and procedural actions or inactions with regard to the development, revision, reaffirmation, or withdrawal of a CLSI consensus document. The appeals procedures shall provide for participation by all parties concerned without imposing an undue burden on them. Consideration of appeals shall be fair and unbiased and shall fully address the concerns expressed.
These appeals procedures are consistent with the requirements of the American National Standards Institute (ANSI) Essential Requirements. Each objector shall be informed that an appeals process exists within the procedures used by CLSI. The burden of proof to show adverse effect shall be on the appellant.

The CLSI consensus procedure incor¬porates two avenues of appeal: appeal of substantive issues and appeal of procedural issues. Procedural appeals include whether a technical issue was afforded due process. Notice of this process will be incorporated in the comment/response summary published in CLSI consensus documents.

A consensus committee, with its balanced membership, is the consensus body for each project within its assigned area of responsibility. Area committees are structured to ensure balanced focus on consensus management; identification of user needs; liaison with ISO/TC 212, and with other standards development organizations when necessary and appropriate; and participation of experienced and new volunteers. Area committees serve as management groups rather than document-drafting committees. They identify and prioritize consensus-development projects and oversee the development and review of consensus documents within each area of interest.

(Standing) subcommittees have primary responsibility for drafting individual consensus documents and for evaluating and addressing comments received during each phase of the consensus process. Scientific accuracy, practicality, and comprehensibility are to be considered by the subcommittee, with the goal of creating documents of overall high quality and utility.

A working group is a subunit of a (standing) subcommittee. A working group’s assignment is limited in scope and it is disbanded upon completion of the assignment. Short-term assignments that can be handled by working groups include: responding to comments on a CLSI consensus document; writing a single document or section of a document; conducting a special technical study; and, developing comments on a document developed by an organization other than CLSI.

Voting can be accomplished at a committee meeting, during a conference call, or electronically via e-mail. Only document development committee participants designated as members, consensus committee members, and CLSI delegates and alternate delegates are eligible to vote on documents.

CLSI Workspace is our new electronic standards development and voting platform that will replace the current Forums platform! CLSI Workspace will give members and volunteers the ability to develop, vote on, and comment on standards using a faster and easier-to-use solution. We plan to move all document development and voting to this new platform by Summer 2014. Click here to learn more.